OBJECTIVE for DQ of Compression Machine :
The Objective of this DQ of Compression Machine Protocol is to decide and record design to meet the criteria of equipment for qualification. It includes:
- Demonstrate that the design of the Double Rotary Tablet Compression Machine will be competent for reproducibility and consistently within its full dynamic range of operation according to required specifications and as per cGMP and cGEP guidelines.
- Document the initial design of the Double Rotary Tablet Compression Machine for future reference.
- Assure that the design of Double Rotary Tablet Compression Machine is adequate to support the process for which the system is designed.
- Help to ensure that the equipment is designed as per the requirement & to identify Batch Processing Parameters, Equipment limitation, Change over timing and cleaning timing.
- Help to ensure that the necessary utility to run the equipment is identified.
CONTENTS for DQ of Compression Machine
| Title |
| Protocol Pre-Approval |
| Qualification Team and Responsibilities |
| Objective and Scope |
| Objective |
| Scope |
| System Description |
| System Design |
| Design Criteria and Critical Parameter |
| Technical Specification/ Key Design Features |
| Material of Construction |
| Requirements |
| Safety Features |
| List of Documents and Drawings |
| Deviation, Change Control and Corrective Action |
| Summary, Conclusion and Recommendation |
| Protocol Post Approval |
| Abbreviation |
PROTOCOL PRE APPROVAL:
PROTOCOL PREPARED BY:
| Department | Name | Signature | Date |
| Quality Assurance (Officer/ Executive) |
PROTOCOL REVIEWED BY:
| Department | Name | Signature | Date |
| Quality Assurance (Executive/ Manager) | |||
| Production (Executive/ Manager) | |||
| Engineering (Executive/ Manager) |
PROTOCOL APPROVED BY:
| Department | Name | Signature | Date |
| Quality Assurance (Head QA) |
QUALIFICATION TEAM AND RESPONSIBILITIES for DQ of Compression Machine:
| Department | Name | Designation | Sign | Date | |
| Qualification Team | Quality Assurance | ||||
| Production | |||||
| Engineering |
| DEPARTMENT | RESPONSIBILITIES |
| Quality Assurance | Quality Assurance Department shall be responsible for Initiation, Review and Approval of the Design Qualification Protocol. Assist in the verification of Critical Process Parameters, Drawings as per the Specification. Review of Design Qualification Protocol after Execution. Coordination with Production and Engineering to carryout Design Qualification. Monitoring of Design Qualification Activity. Post approval of Design Qualification Protocol after Execution. |
| Production | Production Department shall be responsible for: Review of Design Qualification Protocol. Assist in the verification of Critical Process Parameters, Drawings as per the Specification. Post approval of Design Qualification Protocol after Execution. |
| Engineering | Engineering department shall be responsible for: Review of Design Qualification Protocol. Assist in the preparation of Design Qualification Protocol. To coordinate and support in Design Qualification Activity.To assist in the verification of Critical Process Parameters, Drawings as per the Specification i.e.,GA Drawing.Specification of the sub components/ brought out items, their make, model, quantity and backup records/ brochures.Details of utilities required.Identification of components for calibration.Material of construction of product contact parts.Brief process description. |
SCOPE:
The Scope of this Protocol covers the Design Qualification of Double Rotary Tablet Compression Machine. This Design Qualification Protocol defines and covers the system description, component specification & their material of construction, technical specifications, utility requirements and identification of safety requirements.
SYSTEM DESCRIPTION for DQ of Compression Machine:
The Double Rotary Tablet ECO Press “ECO VII AFR” consists of the following units:
Powder Feeding Unit:
Feed Frame Assembly (S1 & S2):
- Feed Frame: The hopper discharge point lies directly into the feed frame.
- Scrapper: Scrapper is present towards the left side of the frame which is fixed into the feed frame using screw. This scrapper lies with line contact on the turret die table. The excess powder after dosing is scrapped and sent to the proceeding feed frame through a re-circulating bend.
- Re-circulating Bend: This component is responsible for guiding of the powder scrapped out from either of the proceeding feed frame to the proceeding frame.
- Tablet taken off Plate: This component is used in diverting the tablet ejected out after compression. It is suitable on the right end of the feed frame and is fixed using screw in adjustable slots.
- Initial Rejection System and Discharge Unit: Machine is furnished with initial rejection System by using two way discharge chute with flapper. Flapper is programmable controlled with time setting using pneumatic line.
Drive Unit, Turret and Compression Unit:
- Drive Unit: Machine is furnished with main motor 10 HP and worm ring gear unit which produce high torque. The gear box consists of a phosphorus bronze worm that meshes with the external helical gearing of the turret. An ACVFD is provided for speed variation.
- Turret: This is a tool holding body in a single piece structure with ASTM A536 the table and upper & lower cam part of EN 353 structure. The upper piece holds the upper punches, which sets on the upper cam tracks with the cam plate. Similarly the lower piece holds the lower punches that travel on the lower cam tracks and dozer. The dies in the cavities provided in the die table with the help of the locking screw assembly. The lower punches are secured using punch holding device comprising of brake plug, anti turning spring strip and bottom head screw.
- Compression Unit: It consists of:
- Upper Punch Roll Assembly (Front & Rear).
- Lower Punch Roll Assembly (Front & Rear).
- Tablet Thickness Assembly (Front & Rear).
Weight Dozer (S1 & S2):
The assembly is responsible for adjusting the weight of the tablet by varying the depth of fill. The depth of fill is adjusted by the upward and downward movement of the weight adjusting head through a dozer adjusting screw with the help of a lever. The dozer adjustment is done from the base cabinet.
Overload Pressure Release Assembly:
This system control the safety overload mechanism, which governs the maximum pressure level at which particular tablets are being made. The compression hydraulic pressure setting is made prior to compressing of the tablet so as to assure perfect working pressure hydraulic pressure setting adjustment provided at HMI. It can be controlled directly from HMI.
Tablet Discharge Unit: It consists of:
- Ejection Cam
- Tablet Discharge Chute (S1 & S2).
Auto Lubrication Unit:
This is a system provided for the lubrication of all critical pinpoints like lower tracks etc.
Bi-Layer Attachment:
This system provided producing bi-layered tablets. During the bi-layer operation lower S1 cam track is removed and the lower punch is allowed to travel at their full span. Ejection takes place at the S2.
SYSTEM DESIGN for DQ of Compression Machine:
Design Criteria and Critical Parameter:
| Critical Variable | Acceptance Criteria | Reference |
| Application: The Double Rotary Tablet Compression Machine should be able to compress tablets from the lubricated granules and /or pharmaceutical powders. | The Double Rotary Tablet Compression Machine should meet the requirement for compressing tablets from the lubricated granules and /or pharmaceutical powders. | Process Requirement |
| Working: Working of Double Rotary Tablet Compression Machine. | The Double Rotary Tablet Compression Machine should be able to compress tablets from the lubricated granules and /or pharmaceutical powders to the final required degree. | Process Requirement |
Technical Specification/ Key Design Features for DQ of Compression Machine :
| Critical Variable | Acceptance Criteria | Reference | ||
| Equipment | Double Rotary Tablet Compression Machine | Design Requirement | ||
| Model No. | C 300 | Design Requirement | ||
| Serial No. | 228/AV/19-20 | Design Requirement | ||
| Equipment ID. No. | PGT/COM-005 | Design Requirement | ||
| Capacity (Tablets per Hour) | Min. 87600 Tab. Max.700800 Tab. | Design Requirement | ||
| Number of Stations | As per reuirement | Design Requirement | ||
| Type of Punch | Euro BB type | Design Requirement | ||
| Turret Speed | Minimum- 10 RPM, Maximum- 80 RPM | Design Requirement | ||
| Tablet Diameter (Upper Limit) | 13 mm | Design Requirement | ||
| Tablet Thickness | Min. 0.25 mm Max. 8.5 mm | Design Requirement | ||
| Upper Punch Penetration (Main) | Min. 2.0 mm Max. 10.0 mm ( Only 1st Layer) | Design Requirement | ||
| Upper Punch Penetration (Tamp) | Min = 2.0 mm Max = 10.0 mm ( Only 1st Layer) | |||
| Compression Force (Maximum) | 100 KN | Design Requirement | ||
| Electric Supply | 415 V AC, 50 Hz, 3 Phase | Design Requirement | ||
| Main Motor Specification | 11.0 kW/ 15.0 HP, 415 V, 1450 RPM, 50 Hz | Design Requirement | ||
| Total Power (Main + 2 Feeder) | 12.5 KW | Design Requirement | ||
| Feeder Type | Force Feeder System | Design Requirement | ||
| Main Motor | ||||
| Manufacturer | SABAR | Design Requirement | ||
| kW/ HP | 11.0 kW/ 15.0 HP | Design Requirement | ||
| Phase Connection | 3 Phase | Design Requirement | ||
| Voltage | 415 VAC | Design Requirement | ||
| RPM | 1450 | Design Requirement | ||
| Frequency | 50 Hz | Design Requirement | ||
| Main ACVFD Drives | ||||
| Manufacturer | Allen Bradley | Design Requirement | ||
| Model No. | Power Flex 525 | Design Requirement | ||
| Power | 15 HP | Design Requirement | ||
| Feeder ACVFD Drives (Two) | ||||
| Manufacturer | Allen Bradley | Design Requirement | ||
| Model No. | Power Flex 525 | Design Requirement | ||
| Power | 1.0 HP | Design Requirement | ||
| Lubrication Pump | ||||
| Make | Cenlub | Design Requirement | ||
| Model | CIL-F-3847/19 | Design Requirement | ||
| Power Supply SMPS | ||||
| Make | Omron | Design Requirement | ||
| Model | S8VK-C24024 | Design Requirement | ||
| Input | AC 240V, 50/60Hz, 6.5 A | Design Requirement | ||
| Output | DC 24V | Design Requirement | ||
| Feeder Motor (Two) | ||||
| Make | Bonfiglioli | Design Requirement | ||
| kW/ HP | 0.55KW/0.75HP | Design Requirement | ||
| Voltage | 3-Phase | Design Requirement | ||
| Phase | 50 Hz | Design Requirement | ||
| RPM | 1420 | Design Requirement | ||
Material of Construction:
FACILITIES & SUPPORTING UTILITIES for DQ of Compression Machine:
The area details versus machine dimensions shall be verified and recorded before machine fabrication in following table:
FACILITY:
| Equipment/ System Description | Specifications | Reference | |
| Approx. Overall Dimensions | 1720mm X 1750mm X 2070mm | Design Requirement | |
| Orientation of machine with drawings | |||
| Shall Comply the dimensions of drawing. | As per GA Drawing | Design Requirement | |
UTILITIES:
Following utilities should be required for the machine design and installation.
| Description | Specified (Approximately) | Remark |
| Power Requirement | 415 V AC, 50 Hz, 3 Phase Supply. | Design Requirement |
| Compressed Air Connection | 5-8 Kg/cm2 | Design Requirement |
| Dust Extractor | 200 CFM | Design Requirement |
SAFETY FEATURES for DQ of Compression Machine:
| Description | Function | Reference |
| Joints | Welding of Joints without any welding burs. | Safety Requirement |
| Metal Parts | All the metal parts should be properly grounded without any sharp edges. | Safety Requirement |
| Leveling and Balancing | Equipment should be properly balanced and leveled. | Safety Requirement |
| Over Load Relay | Motor will tripped as it gets overload. | Safety Requirement |
| Emergency Stop | Emergency stop push button is pressed. | Safety Requirement |
| Turret motor overload | Turret motor overload | Safety Requirement |
| LH feeder motor overload | LH feeder Overload | Safety Requirement |
| RH feeder motor overload | RH feeder Overload | Safety Requirement |
| LH Fill Cam not in position | LH Side of Fill cam not assembled properly | Safety Requirement |
| RH Fill Cam not in position | RH Side of Fill cam not assembled properly | Safety Requirement |
| Lubrication Motor healthy | Lubrication motor Overload | Safety Requirement |
| Lubrication oil level low | Level of oil low | Safety Requirement |
| Air pressure low | Main Air Pressure Low | Safety Requirement |
| LH Powder level low | Powder level is low the sensor | Safety Requirement |
| RH Powder level low | Powder level is low the sensor | Safety Requirement |
| Machine guard open | Machine guards open | Safety Requirement |
| Door for Electrical panel Box open | electrical panel door is open | Safety Requirement |
| Batch size completed | Overshooting of pre set aggregate tablets quantity to be compressed | Safety Requirement |
| Batch No not entered | Batch No. is not entered | Safety Requirement |
| LH Tablet Ejection Cam Assembly not in position | LH Ejection cam not proper fitted on lower side of cam track | Safety Requirement |
| RH Tablet Ejection Cam Assembly not in position | RH Ejection cam not proper fitted on lower side of cam track | Safety Requirement |
| LH Fill Size not proper | if fill cam size not set with the actual fill cam | Safety Requirement |
| RH Fill Size not proper | if fill cam size not set with the actual fill cam | Safety Requirement |
| LH Depth of die fill motor overload | LH Die fill motor overload | Safety Requirement |
| RH Depth of die fill motor overload | RH Die fill motor overload | Safety Requirement |
| LH Pre Tab. Thickness motor overload | LH Side of Pre tablet thickness motor overload | Safety Requirement |
| RH Pre Tab. Thickness motor overload | RH Side of Pre tablet thickness motor overload | Safety Requirement |
| Manually Operated Hand Wheel attached | Check Hand wheel attached in lower side of cabinet | Safety Requirement |
| LH Feeder jammed | Too much powder present in feeder | Safety Requirement |
| RH Feeder jammed | Too much powder present in feeder | Safety Requirement |
| RH Main Tab. Thickness motor overload | RH Side of Main tablet thickness motor overload because of excessive load | Safety Requirement |
| LH Main Tab. Thickness motor overload | LH Side of Main tablet thickness motor overload because of excessive load | Safety Requirement |
| LH Ind. Pre comp. Force High | When Compression force of any individual punch of LH is High with respect to set limit | Safety Requirement |
| RH Ind. Pre comp. Force High | When Compression force of any individual punch of RH is High with respect to set limit | Safety Requirement |
| LH Ind. Main comp. Force High | When Compression force of any individual punch of LH is High with respect to set limit | Safety Requirement |
| RH Ind. Main comp. Force High | When Compression force of any individual punch of RH is High with respect to set limit | Safety Requirement |
| Tablet Ejection force high | when ejection force of any individual Punch gets higher than the set Ejection force value | Safety Requirement |
| LH Standard Deviation beyond Limit | Standard deviation limit is not in Set Range | Safety Requirement |
| RH Standard Deviation beyond Limit | Standard deviation limit is not in Set Range | Safety Requirement |
| Lower punch stiffness beyond limit | Lower punch getting jammed at the time of lifting at dozer side | Safety Requirement |
| Upper punch stiffness beyond limit | upper punch getting jammed at the time of lifting at lifting Cam | Safety Requirement |
| RH Permitted Tab Rej High in 1 revolution | RH Tablet Rejected Higher than Set value | Safety Requirement |
| LH Permitted Tab Rej High in 1 revolution | LH Tablet Rejected Higher than Set value | Safety Requirement |
| Permitted Rej. Tablet high /batch | Rejection higher than the set rejection value /Batch | Safety Requirement |
| Turret Encoder calibration Disturb | Encoder position disturb due to heavy load | Safety Requirement |
| LH Depth of Die fill At Min /Max Limit | LH Side of depth of die reach its minimum value or maximum value | Safety Requirement |
| RH Depth of Die fill At Min /Max Limit | RH Side of depth of die reach its minimum value or maximum value | Safety Requirement |
| LH Pre Tab. Thickness At Min /Max Limit | LH pre side of Tab. Thickness reach its minimum value or maximum value | Safety Requirement |
| RH Pre Tab. Thickness At Min /Max Limit | RH pre side of Tab. Thickness reach its minimum value or maximum value | Safety Requirement |
| LH Main Tab. Thickness At Min /Max Limit | LH Main side of Tab. Thickness reach its minimum value or maximum value | Safety Requirement |
| RH Main Tab. Thickness At Min /Max Limit | RH main side of Tab. Thickness reach its minimum value or maximum value | Safety Requirement |
| Compaction Force Control OFF | If Compaction force Selection is 0 ,In parameter screen . | Safety Requirement |
LIST OF DOCUMENTS AND DRAWINGS:
Vendor shall provide the following documents, manuals and drawings.
| S. No. | Name of the Document/ Manual/ Drawing | Reference |
| Operational and Maintenance Manual | Process Requirement | |
| Manual of bought out items | Process Requirement | |
| P & ID Drawing | Process Requirement | |
| GA Drawing | Process Requirement | |
| Test Certificate of Material of Contact Parts | Process Requirement | |
| Validation Documents | Process Requirement | |
| Electrical Wiring Diagram | Process Requirement |
DEVIATION, CHANGE CONTROL AND CORRECTIVE ACTIONS: Any Deviation or modifications in to the equipment should be performed in accordance with the appropriate change control procedure. A separate assessment shall be made, if any changes or modifications are requested, and shall be done either by vendor and approved by company.
DEVIATION: Any Deviation or Modification to the Compression Machine shall be recorded:
| S. No. | Specification | Deviation | Checked by | Verified by |
CORRECTIVE ACTIONS: Corrective actions to be taken up as per approved change control and record the corrective action.
| S. No. | Deviation | Corrective Actions | Action taken by Vendor | Checked by | Verified by |
SUMMARY, CONCLUSION AND RECOMMENDATION:
After completion of Design Qualification activity, record the summary, conclusion and recommendation for further action.
PROTOCOL POST APPROVAL:
This is to certify that Double Rotary Tablet Compression Machine is designed as per GMP & requirements and the equipment design fulfill the cGMP requirements.
Approved By:
| Department | Name | Signature | Date |
| Production (Head) | |||
| Engineering (Head) | |||
| Quality Assurance (Head) |
ABBREVIATIONS:
| Abbreviation | Full Form |
| AC | Alternating Current |
| ACVF | AV Variable Voltage Frequency Drive |
| AISI | American Iron & Steel Institute |
| Amp | Ampere |
| ASTM | American Society for Testing and Materials |
| cGEP | Current Good Engineering Practices |
| cGMP | Current Good Manufacturing Practices |
| Dia. | Diameter |
| DQ | Design Qualification |
| FLP | Flame Proof |
| GA | General Assembly |
| HP | Horse Power |
| Hz | Hertz |
| IP | Industrial Protection |
| Kg | Kilogram |
| kW | Kilo Watt |
| MCB | Miniature Circuit Breaker |
| mm | Millimeter |
| MMI | Man Machine Interface |
| MOC | Material of Construction |
| No. | Number |
| P & ID | Piping and Instrumentation Drawing |
| PLC | Programmable Logic Controller |
| RPM | Revolution per Minute |
| SMPS | Switch Mode Power Supply |
| SS | Stainless Steel |
| VFD | Variable Frequency Drive |